Noxopharm Ltd (ASX:NOX) plans to expand its NOXCOVID clinical program after receiving “highly encouraging” preliminary top-line data from its Phase 1 clinical trial for patients with coronavirus.
The clinical-stage drug development company is positioning Veyonda® (idronoxil) as an anti-inflammatory drug in COVID-19 patients with moderate disease intended to stop progression to severe disease.
Its aim is to suppress a self-harming inflammatory response to damaged lung tissue without compromising a protective immune response to the coronavirus.
The company is seeking to pursue the use of Veyonda in both in-hospital and outpatient management.
Preliminary discussions are underway for participation in funded clinical trial platforms.
Study results
A total of 37 of the 38 patients hospitalised with moderate respiratory disease and elevated proinflammatory markers were able to complete their treatment course of Veyonda daily for 14 days and be discharged.
Only one patient required mechanical ventilation and this patient was the only death in the full analysis group.
A total of 41 patients received at least one dose of Veyonda but needed to have had at least 12 days of Veyonda treatment to be included in the full analysis group, with 38 patients achieving this.
The Safety Steering Committee declared each dose cohort as safe including the highest dose of 1,800 mg.
Global partnership studies
On the basis of the data, Noxopharm, in partnership with Hudson Institute of Medical Research now will seek to have Veyonda join one or more of the platform programs being conducted globally looking to identify a basket of treatments for COVID-19 disease.
These global clinical studies are being undertaken as a matter of urgency in the expectation that new variants may challenge the protection offered by current vaccines, potentially returning the world to an emergency situation where hospital services are under stress.
Noxopharm is unaware of any drugs with a similar purpose to that of Veyonda being tested in those studies.
Following this Phase 1 study, it will be important to test the effects of Veyonda in a larger randomised controlled study.
Two clinical scenarios
The lack of any safety concerns with Veyonda in COVID-19 patients, plus its self-administration, leads Noxopharm to see Veyonda holding promise in at least two clinical scenarios:
➢ Treating patients with moderate disease who are admitted to hospital, and
➢ Treating patients with milder disease on an outpatient basis to avoid hospitalisation.
Well-tolerated anti-inflammatory
Noxopharm CEO and managing director Graham Kelly said: “With the support of Hudson Institute, a key partner in determining this potential anti-inflammatory benefit of Veyonda, Noxopharm is now in the process of reaching out to a number of local and global initiatives involved in preparing for ongoing challenges from this pandemic.
“We are targeting, in particular, those trials involving hospitalised patients with moderate disease as well as those focusing on out-patient treatment strategies.
“The world is entering unchartered waters with health authorities worldwide seeking a basket of treatments capable of filling cracks that may come from new variants of the virus.
“We see a well-tolerated anti-inflammatory as a key part of that armoury.”
Address gap in COVID therapeutics
Clinician-scientist Marcel Nold, Professor of Paediatric Immunology at Monash University and Hudson Institute, and paediatrician at Monash Children’s Hospital, a world-renowned researcher in the field of cytokine biology and interventional immunology, said: “In Veyonda, Noxopharm has an exciting opportunity at hand.
“Based on what is known today, its properties give it the potential to address a gap in our armoury of COVID therapeutics: patients can self-administer, allowing its use at home; its mechanism of action may enable treatment of moderately-ill COVID patients; and, importantly, it could also be effective against other viruses.”
"Highly encouraging" results
Noxopharm’s Kelly added: “Our target patients are those with a moderate degree of pneumonia experiencing breathing difficulties.
“Behind this pneumonia is an inappropriately excessive inflammatory response to the presence of the virus in the lungs.
“The objective is to use Veyonda to dampen that inflammatory response before it escalates to the point of triggering an even greater inflammatory response that can go on to cause even more widespread tissue damage.
“The challenge is to dampen down the inflammatory response without compromising the ability of the body to fight the virus.
“No major safety issues were identified in the trial, and the recovery of 37 of 38 patients rated as having moderate disease requiring hospitalization and supplementary oxygen for the majority of patients, can be described as highly encouraging.
“Critically, only 1 of the 38 patients who received the full course of Veyonda treatment progressed to severe COVID-19 symptoms requiring mechanical ventilation, and that patient eventually died.
The study was conducted at three sites in the Republic of Moldova and managed by a UK-based contract research company, with blood cytokine/biomarker assays and clinical data analysis, including statistical analysis conducted in Australia.